Senior Staff Scientist IVD

Organization
Thermo Fisher Scientific
Job Location
Carlsbad, CA
Job Description

Sr Staff Scientist IVD 

This position will play a pivotal role within the Ion Torrent clinical product development. The unique individual selected for this position will have high visibility throughout the company. Responsibilities include interacting with cross-functional teams from R&D, operations, quality, and regulatory affairs. If you have experience in DNA sequencing and developing assays in the in vitro diagnostics industry, this could be a very exciting position for you. 

Duties:

  • Will develop and validate an automated next generation IVD sequencing system based on Ion Torrent technology with the objective of meeting FDA regulatory requirements for commercialization.
  • You will apply your management and laboratory skills and experience working in the regulatory environment for IVD product development, verification and validation, manufacturing and transfer, and commercialization.
  • The ability to communicate with stakeholders, manage projects, meticulously document and communicate results to diverse audiences is important aspects of this role.
Requirements

Minimum Qualifications (must have)

  • MS or Ph.D. in molecular biology, chemistry or equivalent discipline.
  • At least 10 years of experience in commercial assay development setting.
  • Experience in IVD assay development including: reagent development and optimization, assay protocol optimization, verification and validation protocol writing and execution, conformance with IVD design control regulations.
  • Proven experience in the development of quality control methods and specification setting.
  • Solid knowledge and laboratory skills in nucleic acid analysis including PCR amplification and purification.
  • Previous experience managing a technical team.
  • Excellent organizational, record keeping and communication skills.
  • A strong work ethic to generate high quality data under tight deadlines in a fast-pace environment, collaborative and proactive attitude a must.

 

Preferred Qualifications (nice to have)

  • Experience in Next Generation Sequencing is a big plus.
About Our Organization

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $17 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.